The Fraunhofer Center for Molecular Biotechnology in Newark, Del., the Fraunhofer Center for Manufacturing Innovation (CMI) in Boston, the Boston University College of Engineering, and the biopharmaceutical company iBio Inc., in Newark, Del., announced April 22 that they have developed a fully automated, scalable "factory" that uses natural (non-genetically-modified) green plants to efficiently produce large quantities of vaccines and therapeutics within weeks. Such a rapid vaccine production facility will play a crucial role in addressing and containing future pandemics and emerging biological threats.
This first-of-a-kind, plant-based vaccine factory, takes advantage of plant viral vector technology developed by Fraunhofer CMB for the biopharmaceutical company iBio. The technology has the capability to produce specific proteins within the leaves of rapidly growing plant biomass. The factory's robotically tended machines, designed by Fraunhofer CMI, plant seeds, nurture the growing plants, introduce a viral vector that directs the plant to produce a target protein and harvest the biomass once the target has accumulated in the plant tissue.
"Traditional methods of vaccine production can take many months. Our plant-based technology provides the means for rapid, large scale production of vaccine material in a cost effective manner," said Dr. Vidadi Yusibov, executive director of CMB. "This technology has the potential to revolutionize how biological materials are manufactured. By partnering with CMI and Boston University, we engineered agricultural and molecular biology into scalable automated processes to establish the first cGMP (current Good Manufacturing Practices) facility for plant-based protein production."
The factory was designed to be time, cost and space efficient. It has the capacity to grow tens of thousands of plants in one batch. The plants are grown in multi-plant trays that are used to handle and transport the plants to the different processing stations. To automate the process, robots glide up and down a track, tending the plants – delivering trays from the lighted, irrigated growth modules to each processing station at the appropriate time.
"In order to quickly produce large quantities of vaccine material or other protein-based medicines such as antibodies in compliance with cGMP, it was necessary to develop a consistent, repeatable process. We have taken a biological process and turned it into an industrial process," said Andre Sharon, a professor of mechanical engineering at Boston University and director of CMI. "Even though the process of making vaccines from plants includes many aspects of traditional horticulture such as growing, watering and harvesting, we have developed a way to automate those functions to quickly, safely and cost effectively scale up from a few milligrams in a laboratory setting to the many kilograms that would be required in case of a pandemic. Everything was designed from the ground up. The process is faster, less expensive, safer and does not require the sophisticated culturing or fermentation necessary in the current vaccine production processes."
This unique, plant-based vaccine factory resulted from a three-year collaboration between the Fraunhofer USA Centers in Delaware and Boston, which are affiliated with Fraunhofer-Gesellschaft, Europe's largest applied research organization, and Boston University.
"This is a perfect example of coupling engineering expertise and scientific advancement to cost-effectively meet a societal need," remarked Robert Brown, president of Boston University and a chemical engineer. "It is a model for collaboration that we strongly believe in on our campus, as they do at Fraunhofer as well."
Support from the Defense Advanced Research Projects Agency (DARPA) under the Accelerated Manufacturing of Pharmaceuticals program, along with funding from the state of Delaware were key in facilitating the design and construction of the pilot facility in Newark.
"I am impressed by Fraunhofer's innovation and commitment to excellence at the scientific and business levels. I am hopeful that Fraunhofer's promising discoveries will advance vaccines and pleased that these biological state-of-the-art developments are taking place in Delaware," said Delaware Governor Jack Markell.
"We believe the new factory in Delaware demonstrates that public health officials will finally have a rapid, high-performance vaccine production technology to use against emergent threats," said Robert Erwin, president of iBio. "We also expect scalability and efficiency of the expression and manufacturing technology to lead to broad commercial applications."
